The invention, in general, relates to an anchorable bushing for use in lining an opening to limit the size of the opening or to serve as a guide for items insertable into the opening. The device has a particular use as a temporary or permanently installed stoma lining for use in tracheostomy patients.
The problem of anchoring a device to an inaccessible side of a wall is ever present. Various devices have been devised to anchor various objects to a wall, such devices including barbed plugs, screws engaging an expanding leg member, rivets and the like. Few devices exist for anchoring a bushing to a wall, most relying on barbed projections for interfering with the walls defining the opening through which the bushing extends. Such devices are not readily removable from the opening and therefore have limited application. Preferably such anchorable bushings would be releasably anchorable in a wall opening to allow them to be removed from the opening. This would be advantageous in many applications including lining and maintaining a stoma formed during a tracheostomy.
Heretofore, at the time of tracheostomy, a cuffed endotracheal tube is inserted into the patient to permit controlled or assisted mechanical ventilation, removal of secretions and to provide access to the trachea. Currently available tracheostomy tubes provide an air tight seal in the trachea with inflatable cuffs which prevent air passage around the tracheostomy tube, either from the oral pharynx into the trachea and the tracheal bronchial tree distal to the tube, or retrograde from the tracheal bronchial airway past the cuff into the oral pharynx.
During weaning from assisted ventilation, patients are frequently initiated to the weaning process by disconnecting the patient from the ventilator to allow breathing through the open tracheostomy tube, either with air or with a supplemental oxygen supply. The tracheal tube and cuff creates a significant obstruction to the trachea, thereby interfering with the free flow of air in or out of the lungs both from the trachea, pharynx and mouth and from the tracheostomy tube. The tube and cuff markedly impedes any flow of air from the oral-pharynx in or out of the lungs.
When patients are able to be weaned from the assisted ventilation device, frequently the tracheostomy tube is changed to a non-cuffed tube to reduce the added obstruction of the tracheostomy tube and cuff and to provide a channel to clear secretions from the trachea and bronchial airways in the lungs. Non-cuffed tubes, have no air tight sealing cuffs and impose less obstruction to the trachea, but they still impede the free flow of air in and out of the lungs past the tracheostomy tube between the trachea and the oropharynx. To alleviate this impedance to air flow, tracheostomy tubes have been developed with a fenestration to provide communication between the oropharynx, through the fenestration into the trachea to allow for movement of air both around and through the tracheal tube fenestration and in and out of the lungs from the oropharynx.
Patients fitted with a non-cuffed tube may, however, not be fully recovered and therefore if the patient should again require assisted ventilation, the non-cuffed tube must be removed and a cuffed tube inserted to commence assisted ventilation. The aforementioned current cuffed tracheostomy tubes make it difficult to initiate spontaneous and normal breathing through the oropharynx because they are a mechanical obstruction in the trachea. Consequently, a tracheal tube change is frequently required to facilitate the weaning process. This can be uncomfortable to the patient and can subject the patient to the complications of frequent intubation and extubation.
Another problem with current ventilation methods is that during the weaning process, it is frequently necessary to maintain tracheal access to the lungs to assist in clearing secretions. In patients successfully weaned, the clearing of secretions is normally accomplished by coughing. An effective patient initiated cough requires a closed glottis to allow a pressure build-up, and a sudden decompression, when the glottis is opened to eject secretions. An open tracheostomy tube with an open channel from the trachea to the exterior of the body, precludes such a pressure build-up and therefore results in an ineffective, spontaneous cough.
Existing tracheostomy tubes must be inserted through an established tracheostomy. When the tube is removed from the patient, however, the stoma begins to heal. The healing process can take as little as 24 hours after which time reinsertion of the tracheostomy tube is impossible without a surgical revision to the stoma. Consequently further surgery is required in the event that further access to the trachea is necessary.
The above problems with assisted ventilation methods heretofore practiced arise because of the need to insert a plurality of different tubes into the ventilation opening at various stages of the weaning process, because of the need to close the ventilation opening to enable an effective cough once the patient has been successfully weaned and because of the rapid healing of a stoma. The insertion of the various tubes into the ventilation opening can be quite uncomfortable to the patient and closure of the opening is virtually the only way of enabling a patient to cause an effective spontaneous cough. With regard to healing of the stoma, it would be desirable to maintain the stoma until it is known for certain that it is no longer required.
One device which attempts to solve the above problems is the Olympic Trach-Button (trademark) which is a self retaining hollow cannula having an expansion lock comprised of a plurality of "petals" on a distal end thereof. The cannula is inserted into a tracheal stoma and a closure plug is inserted into the hollow cannula to expand the petals causing them to interfere with the anterior tracheal wall to prevent the cannula from being ejected. The closure plug or a ventilator adapter must always be inserted in the cannula in order to keep the petals expanded. Furthermore the cannula is of a fixed length and therefore spacers must be used to adapt it to fit the patient's stoma. Such spacers offer adjustment of the length of the cannula in discrete steps only and the spacers can irritate the exterior of the stoma resulting in discomfort to the patient. Cuffed or non-cuffed tracheostomy tubes or suction tubes may be inserted through the cannula, into the patient, to perform their respective functions.
The present invention addresses the problems with the Olympic Trach-Button and more generally addresses the problem of anchoring a bushing in a wall having only one accessible side. Cuffed, non-cuffed tracheostomy tubes or suction tubes may be inserted through the cannula, into the patient, to perform their respective functions.